MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-03 for STORTZ N6377 * manufactured by Bausch & Lomb Surgical, Inc..
[151666]
During tonsillectomy surgery, tonsil snare malfunctioned while dr was removing the tonsil - tonsil snare would not cut completely through the tonsil. Dr had to use scissors to remove tonsil. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018619 |
| MDR Report Key | 273128 |
| Date Received | 2000-04-03 |
| Date of Report | 2000-03-29 |
| Date of Event | 2000-03-22 |
| Date Added to Maude | 2000-04-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORTZ |
| Generic Name | TONSIL SNARE |
| Product Code | KBZ |
| Date Received | 2000-04-03 |
| Model Number | N6377 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 264403 |
| Manufacturer | BAUSCH & LOMB SURGICAL, INC. |
| Manufacturer Address | 499 SOVEREIGN CT. MANCHESTER MO 63011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-03 |